Currentselect_healthPolicy CCP.1336

Digestive enzyme cartridge (RELiZORB)

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Defines coverage and limitations for the in-line digestive enzyme cartridge RELiZORB for members with cystic fibrosis and confirmed exocrine pancreatic insufficiency receiving enteral nutrition, including authorization limits and reauthorization conditions.

Policy Summary

Payerselect_health

PolicyDigestive enzyme cartridge (RELiZORB)

Policy CodePolicy CCP.1336

Change TypeMaterial updates and FDA indication expansion

Effective DateMay 2, 2026

Last ReviewMay 1, 2026

Next Review DateSep 1, 2027

Key ActionObtain prior authorization and provide documentation of cystic fibrosis, confirmed exocrine pancreatic insufficiency, ongoing enteral nutrition, and concurrent pancreatic enzyme replacement therapy.

SourceLink

POLICY UPDATE CHANGES

Coverage statement specifies RELiZORB may be medically necessary for pediatric members, including neonates and infants in stable health with cystic fibrosis and confirmed exocrine pancreatic insufficiency receiving enteral nutrition and pancreatic enzyme replacement therapy.

Expanded FDA indication to include children aged one year and older and adults, based on retrospective review supporting use in ages one to two years.

Policy reorganized findings and incorporated three newly identified sources including two international guidelines and one multicenter retrospective study; no coverage changes were warranted.

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Currentselect_healthPolicy CCP.1336

Digestive enzyme cartridge (RELiZORB)

Customize your policy alerts

Sign up for select_health Policy CCP.1336 alerts

Get alerted when Policy CCP.1336 changes without checking for updates manually.

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Policy Summary

Payerselect_health

PolicyDigestive enzyme cartridge (RELiZORB)

Policy CodePolicy CCP.1336

Change TypeMaterial updates and FDA indication expansion

Effective DateMay 2, 2026

Last ReviewMay 1, 2026

Next Review DateSep 1, 2027

SourceLink

POLICY UPDATE CHANGES

Expanded FDA indication to include children aged one year and older and adults, based on retrospective review supporting use in ages one to two years.

Policy reorganized findings and incorporated three newly identified sources including two international guidelines and one multicenter retrospective study; no coverage changes were warranted.

90 daysinitial authorization duration

up to 6cartridges per 24h (initial)

180 daysreauthorization interval

FDA: 2015; 2025regulatory milestones

RCTs + obsevidence

Coverage Criteria for RELiZORB

Medically necessary coverage

Covered when ALL of the following are met:

Primary coverage criteria: Member has cystic fibrosis; has confirmed exocrine pancreatic insufficiency; is receiving ongoing enteral nutrition; is receiving pancreatic enzyme replacement therapy; is a pediatric member (including neonates and infants in stable health) or an adult consistent with the FDA indication.

Based on Select Health coverage statement and FDA indication expansion.

Authorization limits and reauthorization

Authorization and duration criteria

Authorization limits: Initial authorization: up to six single-use cartridges per 24-hour period for up to 90 days. Reauthorization: every 180 days and conditioned on documentation of continued weight gain and resolution of gastrointestinal symptoms.6 cartridges/24h; 90 days initial; reauth every 180 days

Prior authorization required; reauthorization contingent on clinical improvement as specified in policy.

Investigational uses

Not covered / investigational

Investigational uses: All other uses of a digestive enzyme cartridge not meeting the covered indication (cystic fibrosis with confirmed exocrine pancreatic insufficiency receiving enteral nutrition and pancreatic enzyme replacement therapy) are considered investigational and will be reviewed on a case-by-case basis.

Requests for uses outside the covered indication may be denied.

All other uses of a digestive enzyme cartridge outside the specified indication for cystic fibrosis with confirmed exocrine pancreatic insufficiency receiving enteral nutrition are considered investigational and will be reviewed on a case‑by‑case basis.

Use of a digestive enzyme cartridge for indications that are not supported by documentation of cystic fibrosis with confirmed exocrine pancreatic insufficiency and ongoing enteral nutrition with pancreatic enzyme replacement therapy is not supported (investigational). Such requests will be evaluated individually and may be denied when they do not meet the covered clinical criteria.

Related Codes and Billing

Related enteral nutrition HCPCS codesHCPCS

B4149	Blenderized natural foods with intact nutrients, 100 cal = 1 unit
B4150	Nutritionally complete with intact nutrients, 100 cal = 1 unit
B4152	Nutritionally complete, calorically dense (≥1.5 kcal/mL), 100 cal = 1 unit
B4153	Hydrolyzed proteins (amino acids/peptide chain), 100 cal = 1 unit
B4154	Special metabolic needs (excludes inherited diseases), 100 cal = 1 unit
B4155	Nutritionally incomplete/modular nutrients, 100 cal = 1 unit
B4157	Special metabolic needs for inherited disease of metabolism, 100 cal = 1 unit
B4158	Pediatric-specific enteral formulas (various types), 100 cal = 1 unit
B4159	Pediatric-specific enteral formulas (various types), 100 cal = 1 unit
B4160	Pediatric-specific enteral formulas (various types), 100 cal = 1 unit

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Provider Requirements and Authorization Process

Prior Authorization

Prior authorization required; initial limits and duration

Prior authorization is required for RELiZORB. Initial authorization is limited to up to six single-use cartridges per 24-hour period for up to 90 days; reauthorization is every six months (180 days) and requires documentation of continued weight gain and gastrointestinal symptom resolution.

Consult appropriate coding/billing resources when submitting requests (see related HCPCS codes).

Step Therapy

Therapy sequencing: start with standard enzyme therapy and enteral nutrition

Use of an inline digestive enzyme cartridge should be considered only after usual care approaches are addressed; pancreatic enzyme replacement therapy and enteral nutrition are standard alternatives and the cartridge may be individualized for patients with inadequate response to usual enzyme dosing or persistent gastrointestinal issues.

RELiZORB contains lipase only and does not replace protease or amylase; supplemental pancreatic enzyme replacement therapy is still needed when indicated.

Background and Rationale

Exocrine pancreatic insufficiency results from inadequate production of pancreatic enzymes (including lipase) required for digestion, particularly of fats; patients frequently require pancreatic enzyme replacement therapy and enteral nutrition to meet nutritional goals. For patients with persistent malabsorption despite standard enzyme therapy, an in‑line digestive enzyme cartridge (RELiZORB) is designed to hydrolyze fats in enteral formula by providing immobilized lipase inline with the feeding system.

Definitions

RELiZORB — inline digestive enzyme cartridge definition

Device descriptionAn in-line digestive enzyme cartridge (RELiZORB) containing immobilized lipase covalently bound to polymeric beads that fits between the enteral feeding pump and the feeding tube to hydrolyze fats in enteral formula.

Mechanism of actionHydrolyzes fats in enteral formula by providing immobilized lipase that mimics pancreatic lipase activity during infusion.

PlacementAttaches inline between the infusion (enteral feeding) pump and the implanted feeding tube for use during enteral nutrition delivery.

Regulatory statusFDA de novo classification in 2015 (product code PLQ, regulation 876.5985) with subsequent Class II 510(k) marketing approval; indication expanded for use in children aged ≥1 year and adults (FDA summary 2025).

Intended populationPatients with exocrine pancreatic insufficiency receiving enteral nutrition who require hydrolysis of fats in enteral formula.

Policy Summary

Payerselect_health

PolicyDigestive enzyme cartridge (RELiZORB)

Policy CodePolicy CCP.1336

Change TypeMaterial updates and FDA indication expansion

Effective DateMay 2, 2026

Last ReviewMay 1, 2026

Next Review DateSep 1, 2027

SourceLink

On This Page

Documentation Required

Required clinical documentation for initial authorization and reauthorization

Submit documentation that confirms the member has cystic fibrosis, confirmed exocrine pancreatic insufficiency, is receiving ongoing enteral nutrition, and is receiving pancreatic enzyme replacement therapy; for reauthorization include evidence of continued weight gain and resolution of gastrointestinal symptoms.

Clinical notes or diagnostic test results confirming cystic fibrosis and exocrine pancreatic insufficiency.
Records showing ongoing enteral feed regimen and pancreatic enzyme replacement therapy.
Weight trends and documentation of GI symptom improvement for reauthorization.

Denial Risk

Denial triggers: exceed limits or non-covered indications

Requests that exceed the policy limits or that are for uses outside the covered indication are subject to denial—specifically, requests for more than six single-use cartridges per 24-hour period, initial durations beyond 90 days, or uses not meeting the cystic fibrosis with confirmed exocrine pancreatic insufficiency receiving enteral nutrition indication.

All other uses of a digestive enzyme cartridge are considered investigational and will be reviewed case-by-case; such uses may be denied.

Exocrine pancreatic insufficiency — definition and manifestations

DefinitionA clinical condition characterized by deficient pancreatic enzyme production (amylase, protease, lipase) resulting in inadequate digestion and particularly fat malabsorption.

Common causesChronic pancreatitis, cystic fibrosis (most common in children), pancreatic duct obstruction, pancreatic surgery, Shwachman-Diamond syndrome; non‑pancreatic causes include celiac disease, Crohn's disease, Zollinger‑Ellison syndrome, and motility disorders.

Typical clinical manifestationsSteatorrhea, continued weight loss, abdominal discomfort/bloating, loss of appetite, and low circulating levels of micronutrients and fat‑soluble vitamins (A, D, E, K).

Diagnostic approachesFecal fat quantification and 13C‑mixed triglycerides breath test are among the most accurate; fecal elastase-1 assay, blood macro/micronutrient testing, imaging, and direct pancreatic function tests may also be used.

Management relevancePatients often require pancreatic enzyme replacement therapy and/or enteral nutrition; RELiZORB provides an option to hydrolyze fats in enteral formula when oral enzyme mixing is not feasible or effective.